JP4898988B2 - Retrievable vena cava filter with primary struts to enhance retrieval and delivery performance - Google Patents

Description

[Cross-reference to related technologies]
This application is U.S. Provisional Application No. 60 / 562,809, filed "collection and delivery performance retrievable vena cava filter having a primary struts to increase the" April 16, 2004, which is referred (the entire contents of Claiming the benefit of which is made a part of the disclosure of this specification by specifying the source.

This application is also referred to as US Provisional Application No. 60 / 562,813, filed April 16, 2004, which is referred to as “a retrievable filter for capturing clots ” (the entire contents of which are expressly incorporated by reference). The benefit of which is hereby incorporated by reference.

In addition, this application is a US Provisional Application No. 60 / 562,909 filed on Apr. 16, 2004, which is referred to as a “blood clot filter with struts having an expanded memory state” (the entire contents of which are clearly identified) The benefit of which is hereby incorporated by reference.

This application is also referred to as US Provisional Application No. 60 / 563,176, filed April 16, 2004, which is referred to as “a blood clot filter with struts having a folded memory state” (the entire contents of which are expressly cited). The benefit of which is hereby incorporated by reference.

The present invention relates to medical devices. More particularly, the present invention relates to a recoverable vena cava filter that is placed percutaneously in and removed from the vena cava of a patient.

Filter devices placed percutaneously in the vena cava have been used for over 30 years . There is a need for a filter device for patients with trauma , orthopedic patients, neurosurgery patients, or patients with medical conditions that require bed rest or no movement. In such conditions, the need for filtering devices arises therefore the possibility of thrombosis in patients with peripheral vascular system such as blood clots leads to the risk of thrombosis or thrombosis of downstream peeled from the vessel wall. For example, such a thrombus, depending on the size, there is a risk of pulmonary thrombosis moving blood clot passes through the heart from peripheral vascular system into the lungs.

For example, a filter device can be deployed in the vena cava of a patient when anticoagulant therapy is contraindicated or fails. Typically, the filter device can be passed medical condition or disease in need of this device is a permanent implant remains much implanted in the patient. In recent years, filters have been used or considered for preoperative patients and patients prone to thrombosis that risk pulmonary thrombosis.

While the benefits of vena cava filters have been well established , there is room for improvement. For example, the filter was not considered to be recoverable from the patient due to the possibility of endothelialization of the filter during treatment or because of the fibrous reactant that adheres to the endothelial cells. After deploying the filter within the patient begins accumulate around the struts of the filter proliferative vascular intimal cells in contact with the wall of the blood vessel. After some time, such growth prevents filter recovery without the risk of trauma, requiring the filter to remain on the patient. As a result, there was a need for an effective filter that can be recovered after the basic medical condition has stopped .

Moreover, conventional filters are generally eccentric or inclined with respect to the filter hub and the longitudinal axis of the blood vessel into which the filter is inserted. As a result, a filter having a hub and a retrieval hook engages the vessel wall along its length and is potentially endothelialized therein. This condition is illustrated in prior art FIG. 1 a where a prior art filter 113 is delivered through a patient's blood vessel 150 by a delivery sheath 125. In this case, there is a possibility of the endothelialization of the filter into the blood vessel over a considerable length of the filter wire. As a result, the filter becomes a permanent implant in less time than the others.

Furthermore, further improvements are preferably made regarding delivery or retrieval of the vena cava filter. For delivery of a vena cava filter, an introducer with an introducer tube is inserted percutaneously into the patient's vena cava through the femoral or jugular vein. A portion of introducer 120 is shown in prior art FIG. 1b, where prior art filter 113 is percutaneously delivered through the patient's jugular vein 154. FIG. As shown, the filter 113 in the folded state is placed at the distal end of the inner sheath 122 with its anchor hook 116 extending beyond the distal end 121. Then, in order to avoid scratching or rubbing undesirable anchor hook 116 for inlet tube 130, placing the outer sheath 126 over the inner sheath 122. The inner and outer sheaths 122, 126 are then moved along with the pusher member 132 through the introducer tube 130 to deliver the filter 113 to the patient's vena cava.

It was a challenge to devise a vena cava filter having features that reduce the problem of undesirable scratching or rubbing of the anchor hook against the outer wall of the introducer or vessel while maintaining the effectiveness of the filter.

One embodiment of the present invention provides a recoverable vena cava filter that is adapted to be easily delivered to and recovered from a patient's vena cava. This filter is shaped for easy delivery and collection. The filter has primary and secondary struts, each strut having an arcuate shape extending from the first end, arcuate along the longitudinal axis , and linearly with respect to the radial axis. And segments.

The present invention, in order to capture thrombi in the blood vessel, to provide a folded state and that has an expanded state retrievable vena cava filter. In one embodiment, the filter comprises a plurality of primary struts. Each expanded primary strut extends from its first end to an anchor hook . Each primary strut extends in an arc along the longitudinal axis and in a straight line with respect to the radial axis. The first ends of the plurality of primary struts are attached together along the longitudinal axis . In addition, the filter includes a plurality of secondary struts. Each expanded secondary strut extends from its first end to its free end. Each secondary strut extends in an arc along the longitudinal axis and in a straight line with respect to the radial axis. The plurality of secondary struts are attached together along the longitudinal axis . The plurality of secondary struts to position the filter in the expanded state to the center of the vessel.

In another embodiment, the recoverable vena cava filter includes a hub that axially houses the first end of the primary strut and the first end of the secondary strut. Furthermore, the filter has a retrieval hook extending from the hub against the plurality of primary struts for the recovery of the filter from the blood vessel.

In yet another embodiment, multiple pairs of secondary struts are positioned between multiple pairs of primary struts. Each pair of secondary struts are twisted together near their connecting ends to form a twisted portion. Twisted portion of the secondary struts effectively stiffen the struts to enhance their centering capabilities, the filter is Ide explosion from being inclined when the filter is deployed in the blood vessel. Thus, the engagement between the strut and the blood vessel is minimized, thereby reducing the possibility that the strut is endothelized within the blood vessel. A further feature of the twisted portion is that it prevents or at least minimizes the secondary struts from tangling with the primary struts.

  Further aspects, features and advantages of the present invention will become apparent from the following description and consideration of the accompanying drawings, taken in conjunction with the accompanying drawings.

In accordance with one embodiment of the present invention, FIG. 2 illustrates the vena cava 50 for the purpose of lysing or capturing thrombus transported by blood that flows toward the heart through the iliac veins 54, 56 and enters the pulmonary artery. Fig . 1 shows the vena cava filter 10 implanted therein . As shown in the drawing, the iliac veins 54 and 56 merge at the joint 58 and enter the vena cava 50. The renal vein 60 from the kidney 62 joins the vena cava 50 at the downstream portion of the junction 58. The portion of the vena cava 50 between the junction 58 and the renal vein 60 constitutes the inferior vena cava 52 in which the vena cava filter 10 is percutaneously deployed through one of the femoral veins. Preferably, the vena cava filter 10 is shorter than the length of the inferior vena cava 52. If the lower part of the filter extends into the iliac vein, the filtering effect decreases, and if the filter wire crosses the origin of the renal vein, the filter wire may interfere with blood flow from the kidney. I don't know.

This embodiment of the present invention will be further described with reference to FIGS. 3-9 where the filter 10 is shown. FIG. 3 a shows the filter 10 in an expanded state with four primary struts 12 each having a first end that exits the hub 11. The hub 11 attaches the first end 14 of the primary strut 12 to the compact bundle by crimping at a center point A along the center or longitudinal axis X of the filter. Hub 11 has a minimum diameter relative to the size of the wire used to form the strut.

Preferably, the primary strut 12 is a superelastic material, stainless steel wire, nitinol, cobalt-chromium-nickel-molybdenum-iron alloy, cobalt-chromium alloy, or any other such as a self-opening or self-expanding filter. Made of a suitable superelastic material. In this embodiment, the primary strut 12 is preferably formed from a wire having a round cross-section with a diameter of at least about 0.018 inches. Of course, it is not necessary that the primary struts have a round or nearly round cross section. For example, the primary strut 12 can take any shape with rounded edges to maintain non-turbulent blood flow.

As shown in FIGS. 3a and 3b, each primary strut 12 has an arcuate segment 15 with a gentle S-shape. Each arcuate segment 16 is configured to bend gently toward the longitudinal axis of the filter 10 and a first curved portion 20 that is gently bent in the longitudinal direction of the filter 10 or away from the central axis X. and which is formed from the second curved portion 23. Each arcuate segment 16 is gently bent so that protrusions or inflection points on the primary strut 12 are sufficiently avoided to help atraumatically engage the vessel wall.

As shown in FIG. 3b, each primary strut 12 terminates at an anchor hook 26 that snaps into the vessel wall when the filter 10 is deployed in the delivery position within the vessel. Primary strut 12 is configured to move between an expanded position for engaging anchor hook 26 with a blood vessel and a folded state for retrieval or delivery of the filter. In the expanded state, each primary strut 12 extends from the first end 14 to the anchor hook 26 in an arc along the longitudinal axis X (as shown in FIG. 3a) and as a radius (as shown in FIG. 8a). It extends linearly with respect to the direction axis R. As shown in FIG. 8 a, the primary strut 12 extends radially from the first end 14 to define a radial axis R. In this embodiment, the primary strut 12 extends linearly with respect to the radial axis R to avoid entanglement with other struts.

As described in more detail below, the gradual bending of the arcuate segments 16, each primary strut 12, as the anchor hook 26 faces the longitudinal axis X for the recovery or delivery of the filter, longitudinal in the folded state It can intersect with other primary struts 12 along the direction axis X.

When the filter 10 is deployed within the blood vessel, the anchor hook 26 engages the wall of the blood vessel to form a first axial portion to secure the filter within the blood vessel. The anchor hook 26 prevents the filter 10 from moving from the delivery position within the indwelling blood vessel. The primary strut 12 is shaped and dimensioned so that when the filter 10 is freely expanded, the filter 10 has a diameter between about 25 mm and 45 mm and a length between about 3 cm and 7 cm. For example, the filter 10 may have a diameter of about 35 mm and a length of about 5 cm. Primary strut 12 has sufficient spring strength to anchor anchor hook 26 into the vessel wall when the filter is deployed.

In this embodiment, the filter 10 has a plurality of secondary struts 30 with connecting ends 32 extending from the hub 11 as shown in FIG. 3a. The hub 11 is attached by crimping the connecting end 32 at the center point A of the secondary strut 30 together with the primary strut. In this embodiment, each primary strut 12 has two secondary struts in juxtaposition therewith. The secondary strut 30 extends from the connecting end 32 to the free end and positions the expanded filter 10 centrally within the blood vessel. As shown, each secondary strut 30 is arced along the longitudinal axis and relative to the radial axis from the coupling end 32 to the free end 34 to engage the anchor hook 26 with the blood vessel. It extends in a straight line. Like the primary struts 12, the secondary struts 12 extend linearly with respect to the radial axis to avoid entanglement with other struts.

The secondary strut 30 may be manufactured from the same type of material as the primary strut 12. However, the secondary struts 30 may have a smaller diameter than the primary struts 12, for example, a diameter of at least about 0.012 inches. In this embodiment, each of the secondary struts 30 includes a first arc portion 40 and a second arc portion 42. The first arc portion 40 extends from the connecting end portion 32 in a direction away from the longitudinal axis X. The second arc portion 42 extends from the first arc portion 40 toward the longitudinal axis X. As shown, two secondary struts 30 are positioned on each side of one primary strut 12 to form part of the network configuration of filter 10. Hub 11 is preferably made of the same material as the primary struts and secondary struts to minimize the possibility of galvanic corrosion or molecular changes in the material due to welding.

When freely deployed, the free end 34 of the secondary strut 30 extends radially outward to a diameter between about 25 mm and 45 mm. For example, the secondary strut 30 may extend radially outward to a diameter between about 35 mm and 45 mm. The second arc portion 42 of the free end portion 34 is engaged with the wall portion of the blood vessel to constitute a second axial portion where the blood vessel wall portion is engaged. The secondary strut 30 functions to fix the position of the filter 10 around the center of the blood vessel in which the filter 10 is deployed.

As a result, the filter 10 has two layers or portions of struts that longitudinally engage the vessel wall. The length of the filter 10 is preferably determined by the length of the primary strut 12. Further, the diameter of the hub 11 is determined by the size of the bundle having the primary struts 12 and the secondary struts 30. In this embodiment, therefore decreasing the diameter of each secondary strut 30, a minimum of eight secondary struts 30 are applied to the entire length of the diameter or the filter 10 of the hub 11. This is accomplished while maintaining the filter 10 in a centered position relative to the blood vessel and is formed as part of the filter network. As shown, an extraction hook 46 extends from the hub 11 on the opposite side of the primary and secondary struts 12, 30.

In this embodiment, each arcuate segment 16 has a thickness of at least about 0.015 inches and a tensile strength between about 285000 pounds per square inch (psi) and 330,000 psi. Each anchor hook 26 is integral with the arc segment 16 and has the arc segment thickness and tensile strength. Each secondary strut 30 has a thickness of at least about 0.031 inches and a tensile strength between about 285000 psi and 330,000 psi.

FIG. 3c shows the filter 10 in a folded state disposed in a delivery / recovery tube 94 for delivery or collection. As shown, the filter 10 is shaped such that each primary strut 12 intersects the other primary struts 12 along the longitudinal axis X. As a result, in the folded state, the anchor hook 26 is configured to reverse for recovery and delivery of the filter 10 or to be inward with respect to the longitudinal axis X. Since the anchor hook 26 is reversed or inward , it is easy to send out and collect the filter 10. For example, the problem that the anchor hook 26 in the folded state may rub, scratch, or peel off the inner wall portion of the delivery / recovery tube is solved . This is because the filter 10 of the present invention is formed so that the anchor hooks 26 face each other in the folded state. Indeed, during delivery or retrieval of the filter 10 through the jugular or femoral vein, a set of inner and outer delivery and retrieval sheaths (see prior art FIG. 1b) may be omitted. Rather, only one delivery / recovery tube with a loop snare mechanism may be used to deliver or retrieve the filter 10 of the present invention.

Moreover, in the folded state, the primary struts 12 are respectively separated from the other primary struts 12 along the longitudinal axis X so that the arcuate segment 16, the first curved portion 20 or the second curved portion 23 occupies the first diameter D1. It is supposed to cross. In this embodiment, the first diameter, a second larger diameter D 2 occupied by the anchoring hooks 26 for collection or delivery of the filter. First diameter of the arcuate segments 16 serves to clear the collection path, during removal of the filter 10 from the patient, it was found to reduce the radial forces acting from the sheath or blood vessel on the anchoring hooks 26. By reducing the radial forces acting on the anchor hook 26, and helps to prevent while taking out the filter 10 from the patient, the anchor hook 26 rub the inner wall of the sheath, scratched or, alternatively peeled or to the the .

It should also be noted that in this embodiment of the invention, the filter 10 may be delivered or collected by any suitable inlet ( delivery or collection) tube . However, it is preferred that the inlet tube has an inner diameter between about 4.5 French and 16 French, more preferably between about 6.5 French and 14 French.

FIG. 4 shows the primary strut 12 in which a distal bend 43 is formed extending radially outward from the longitudinal axis X. As shown in FIG. 4, the distal bend 43 between about 0.5 degrees 2 degrees, preferably may extend outwardly at an angle of 1.0 degrees. The distal bend 43, the filter 10 while maintaining the ability folded for delivery or retrieval, can effectively filtering the thrombus smaller luminal diameter than the other methods that might.

5 in the hub 11 illustrates a cross-sectional view of the filter 10 of Figure 3a. As shown in the figure, the hub 11 accommodates a bundle composed of the first ends 14 of the four primary struts 12 and the connecting ends 32 of the secondary struts 30. Further, FIG. 5 shows the configuration of the primary and secondary struts 12,30. In this embodiment, primary struts 12 are spaced between two secondary struts 30 . Of course, the primary struts 12 Ku such departing from the scope or spirit of the present invention, may be spaced between any other suitable desired number of secondary struts 30.

In this embodiment, FIGS. 6 a and 6 b both show the filter 10 partially deployed in the inferior vena cava 52. FIG. 6a shows that the filter 10 is delivered by the delivery tube 48 through the patient's vasculature , and FIG. 6b shows that the filter 10 is delivered by the delivery tube 50 through the patient's jugular vein. Show. To deploy the filter 10, the delivery tube so that its distal end is in the deployed position, percutaneously inserted into a patient's blood vessel. In this embodiment, a wire guide is preferably used to guide the delivery tube to the deployed position. In FIG. 6a, for delivery through the patient's femoral vein, the filter 10 is in the proximal end of the delivery tube 48 with the extraction hook 46 leading and the anchor hook 26 of the primary strut 12 held by the filter retainer member. Has been inserted .

In FIG. 6b, for delivery through the patient's jugular vein, the filter 10 is inserted into the proximal end of the delivery tube 50 with the anchor hook 26 of the primary strut 12 leading and the removal hook 46 following it. ing. In this embodiment, a pusher wire having a distal end pusher member is routed through the proximal end of the delivery tube 50, so that the filter 10 reaches the distal end of the delivery tube 50 to the desired location. You may push in.

During deployment, the secondary strut 30 expands to first concentrate or balance the filter within the vessel. When the free end of the secondary strut exits the distal end of the delivery tube 48 or 50, the secondary strut 30 expands to the expanded position as shown in FIGS. 6a and 6b. The second arc portion 42 engages with the inner wall of the blood vessel. The second arc portion 42 of the secondary strut 30 functions to stabilize the posture of the filter 10 around the center of the blood vessel. Upon delivery through the jugular vein (FIG. 6b), the filter 10 is then pushed further with a pusher wire (not shown) until the filter 10 is fully deployed.

When the filter 10 is fully deployed in the vena cava , the fixing hook 26 of the primary strut 12 and the second arcuate portion 42 of the secondary strut 30 are in engagement with the blood vessel. The securing hook 26 of the primary strut 12 secures the filter 10 in a deployed position within the blood vessel and prevents the filter 10 from moving through the blood vessel with blood flow. As a result, the filter 10 is supported by two sets of struts spaced axially along its length.

FIG. 7 shows the filter 10 fully expanded after being deployed in the inferior vena cava 52. As shown, the inferior vena cava 52 is broken so that the filter 10 can be seen. The direction of blood flow BF is indicated by an arrow with BF in FIG. Anchor hook 26 at the end of primary strut 12 is shown as being attached to the inner wall of inferior vena cava 52 . The anchor hook 26 , in one embodiment, has a barb 29 that protrudes toward the hub 11 of the filter. These barbs 29 function to hold the filter 10 in the deployed position.

Furthermore, the spring-loaded configuration of the primary strut 12 allows the anchor hook 26 to engage the vessel wall and secure the filter in the deployed position. After the initial deployment, the spine 29 secured to the inner wall of the inferior vena cava 52 is maintained by the pressure of the blood flow acting on the filter 10 . As can be seen in FIG. 7, the second arcuate portion 42 of the secondary strut 30 also has a spring biased configuration to engage the vessel wall.

As can be seen in Figure 7, the hub 11 and removal hook 46 are positioned downstream from the position where the anchor hooks 26 are secured within the vessel. Once the thrombus is captured by the struts 12, 30, it will remain in the filter. So, the eject the filter 10 together with the thrombus from the femoral vein percutaneously. If trying to retrieve the filter 10, preferably gripping the extraction hook 46 by percutaneously introduced is recovered instrument initially vena cava in the direction of the extraction hook 16.

FIG. 8 a shows a reticulated configuration or pattern constituted by primary struts 12, secondary struts 30 and hubs 11 in the radial direction R. The mesh pattern shown in FIG. 8a functions to capture thrombi carried in the bloodstream before reaching the heart and lungs to prevent pulmonary embolism. This mesh pattern is sized to capture and stop thrombus of a size that is undesirable to be carried within the patient's vasculature. Hub, because it is small, the resistance against the flow of blood is minimized.

FIG. 8a shows a reticulated pattern having primary and secondary struts at approximately equal angular intervals relative to each other. This reticulated pattern gives the blood flow a uniform distribution between the primary and secondary struts, increasing the possibility of trapping the thrombus. However, as shown in FIG. 8b, it may be spaced substantially equally and independently in a relative position, each pair in radial axis R 'series of primary struts 312 and a series of secondary struts 330 are understood I want to be. For example, secondary struts 330 may be evenly spaced with respect to other secondary struts 330 and primary struts 312 may be equally spaced with respect to other primary struts 312. As a result, the reticulated pattern in this embodiment shown by the vena cava cross section (along line 8-8) has irregular or uneven spacing between the primary strut 312 and the secondary strut 330. .

FIG. 9 a shows a portion of the collection device 65 used in the procedure of removing the filter 10 from the inferior vena cava 52. In this example, the recovery device 65 is percutaneously introduced into the superior vena cava via the jugular vein. In this procedure , the retrieval catheter or sheath 68 of the retrieval device 65 is inserted into the superior vena cava. A wire 70 having a loop snare 72 at the distal end is removed and passed through the sheath 68 and out of the distal end of the sheath 68. The wire 70 is then manipulated from the proximal end of the retrieval device by any suitable means such that the loop snare 72 captures the extraction hook 46 of the filter 10. The sheath 68 is passed over the filter 10 using counter traction by pulling the wire 70 while pushing the sheath 68.

As the sheath 68 passes over the filter 10, the primary strut 12 and then the secondary strut 30 engage the edge of the sheath 68 and then rotate at the hub 11 towards the longitudinal axis of the filter, or Or it receives bending bending. The rotation towards the longitudinal axis, Ru retracted the ends of the struts 12 and 30 from the vessel wall. In this way, the removal procedure causes only surface damage 74 and small point damage 76 in the vessel wall. As shown, surface damage 74 is caused by the end of the secondary strut 30 and small point damage 76 is caused by the anchor hook 26 of the secondary strut 12. However, it should be noted that any other suitable procedure may be performed to remove the filter from the patient .

Although an embodiment of this apparatus is shown as being preferably constructed from a wire having a round cross-section, this apparatus may be constructed of a tube of suitable material by laser cutting, electrical discharge machine or any other suitable method. It can also be disconnected from.

The primary and secondary struts can be formed from any suitable material that will be a self-opening or self-expanding filter, such as a shape memory alloy. Shape memory alloys have the desirable property of becoming rigid when heated above the transition temperature, ie, returning to a memorized state. A shape memory alloy suitable for the present invention is Ni-Ti, commonly known and commercially available under the name Nitinol. When this material is heated above its transition temperature, the material undergoes a martensite to austenite phase transition to return to its memorized state. The transition temperature is determined by the composition ratio of the alloying elements Ni and Ti and optionally including the added alloy.

In other embodiments, both primary and secondary struts are made from nitinol having a transition temperature slightly below normal human temperature, which is about 37 ° C. (98.6 ° F.). Thus, when the filter is deployed in the vena cava and exposed to normal body temperature, the strut alloy transitions to austenite, the memorized state, which in the present invention is the filter in the vessel. Expanded shape when unfolded. To retrieve the filter, the material is cooled to the filter by transferring the martensite ductile than austenite, to a state where there is more malleable struts. In this way, the filter can be folded into the sheath for easier folding and removal .

In certain embodiments, both primary and secondary struts are made from nitinol having a transition temperature above human normal body temperature of about 37 ° C. (98.6 ° F.). Thus, when the filter is deployed in the vena cava and exposed to normal body temperature, the struts are in a martensitic state and, therefore, these struts are bent or formed into the desired shape , which is an expanded shape in the present invention. enough to have a ductile to. To retrieve the filter, when heating the filter Ru by transferring the alloy to austenite, the filter has a rigid, made to return to a state of being stored is a collapsed configuration in this filter.

In another embodiment shown in FIGS. 10 and 11, the filter 420 has a secondary strut 440 of the four primary struts 438 and eight extending from the hub 442. Each primary strut 438 terminates with an anchor hook 452 having barbs 454. The primary strut 438 ensures that when the filter is deployed in the vena cava 436, the anchor hook 452, in particular the barbs 444, stick into the vessel wall of the vena cava 436 and prevent the filter from moving from the delivery position. Have sufficient spring strength. Pressure due to blood flow acting on the filter contributes to maintaining the barbs 454 secured to the inner wall of the vena cava 436.

A pair of secondary struts 440 are positioned between adjacent primary struts 438. Each secondary strut 440 terminates at the distal end portion 462 facing toward the extending from the hub 442, centered axis 444. These tips 462 are positioned longitudinally between the hub 442 and the anchor hook 454 of the primary strut 438. The connecting ends of each pair of secondary struts 440 positioned between adjacent primary struts are twisted together to form a twisted portion 464.

Since the twisted portion 464 is stiffened sufficiently secondary struts 440 of each pair, in order to provide a suitable balancing force in order to position the filter in the center of the vessel, thinner secondary struts may be used May be. Moreover, additional advantages of twisted portion 464, it is these twisted portion 464 therefore is that say to avoid entanglement and the secondary struts and primary struts.

The secondary strut 440 can be made from the same type of material as the primary strut 438 and can be formed by the same method used to make the primary strut. However, the secondary struts may have a smaller diameter than the primary struts. To form the twisted portion 464, after attaching the secondary struts of each pair positioned between one adjacent primary struts 438 to the hub 442 may be wound in one another. Each twisted portion 464 has one or more twists. For example, each twisted section 464 may have a twist of about 10 points. In some implementations, the number of twists in each twisted portion 464 may be between about 3 and 5 locations . Increasing the number of twists increases the rigidity of the pair of secondary struts that wrap around each other. Hub 442 is preferably made of the same material as the primary and secondary struts to minimize the possibility of electrolytic corrosion .

FIG. 11 shows a reticulated pattern (“net”) composed of primary struts 438, secondary struts 440 and hub 442. This net functions to capture thrombus carried in the bloodstream to prevent the thrombus from reaching the heart and lungs , which causes pulmonary embolism. The net is sized to capture and stop undesired thrombi in the patient's vasculature. As illustrated, strut 438 is substantially equal rather spaced between each strut.

Hub 442 and removal hook 466 attached to the hub are located downstream of the position where the anchor hook 452 is secured to the vessel 436. The thrombus remains in the filter 420 when it is captured by the strut . Then, the filter 420 along with the thrombi Desa taken from the vena cava percutaneously. When attempting to remove the filter 420, the retrieval hook 466 is typically gripped by a retrieval hook that is percutaneously introduced into the vena cava.

In the present invention has been described with respect to preferred embodiments, it is understood in particular ahead of those skilled in the art in light of the teachings can der Runode to perform design change, that the invention is not limited to the above embodiments, of course I will.

1 is a side view of a prior art filter deployed through a patient's vasculature. FIG. 1 is a side view of an introducer assembly having a prior art filter for delivery to a patient's vena cava. FIG. FIG. 3 is a diagram of the anatomy of the renal vein, iliac vein, and vena cava in which one embodiment of the vena cava filter of the present invention is deployed. It is a side perspective view of one embodiment of a vena cava filter in an expanded state. FIG. 3b is a side view of the primary strut of the filter in FIG. 3a according to an embodiment of the present invention. FIG. 3b is a side view of the vena cava filter of FIG. 3a in a folded state and disposed in the introducer tube. FIG. 6 is an enlarged view of a portion of the second arcuate portion of the primary strut of the vena cava filter. FIG. 5 is a cross-sectional view of the hub of the filter of FIG. 3 taken along line 5-5. FIG. 6 is a cross-sectional view of the vena cava showing the filter partially deployed with the extraction hook in front. FIG. 5 is a cross-sectional view of the vena cava showing a filter partially deployed with an anchor hook in front. FIG. 4 is a cross-sectional view of the vena cava with the filter of FIG. 3 deployed. FIG. 8 is a cross-sectional view of the vena cava of FIG. 7a taken along line 8-8. FIG. 8 is a cross-sectional view of the vena cava of FIG. 7a taken along line 8-8 showing another embodiment of the filter. FIG. 4 is a cross-sectional view of a blood vessel with a retrieval sheath engaging the primary strut of the filter of FIG. 3 for retrieval. FIG. 6 is a cross-sectional view of a blood vessel having a filter with a collection sheath folded for removal. FIG. 6 is a cross-sectional view of a blood vessel showing a vena cava filter deployed in a blood vessel according to another embodiment of the present invention. FIG. 11 is a view of the blood vessel and filter of FIG. 10 taken along line 11-11.

Claims (13)

Multiple primary struts;
Multiple secondary struts;
The Bei example, to have a state and expanded state folded, a retrievable filter for capturing thrombi in a blood vessel,
Each primary strut of the plurality of, in the expanded state, in Ankafukkuma from its first end, in an arc along the long side direction axis, and extends linearly in the radial direction, the primary struts of the plurality of The first ends are attached together along the longitudinal axis;
The secondary struts is shorter than the primary struts, each secondary strut plurality of, in the expanded state, the first end in the free end or the portion thereof, in an arc along the longitudinal axis, and A first arc portion extending linearly in the radial direction, extending from the first end of the secondary strut and bending away from the longitudinal axis, and further extending from the first arc portion in the longitudinal axis direction. and a second arcuate portion to bend in a direction along the first end of the plurality of secondary struts are attached together along the longitudinal axis, the secondary struts wherein the plurality of the expanded state are to be positioned at the center in the vessel and the filter in, when the filter is deployed is delivered from the delivery tube, when the anchor hook side of the primary strut is sent and after the anchor hook side In any case sent ahead, the secondary struts to expand earlier than the primary struts engage the blood vessel, it has been made to stabilize the posture of the filter, retrievable filters . A hub adapted to axially accommodate the first end of the plurality of primary struts;
A retrieval hook extending from the hub opposite the plurality of primary struts for retrieving the filter from the blood vessel;
The recoverable filter of claim 1 further comprising:   The arcuate portion has a first curved portion and a second curved portion, the first curved portion extends from the first end, and the second curved portion is the first curved portion. The recoverable filter of claim 1 extending from and terminating at the anchor hook.   The first curved portion is adapted to extend radially from the longitudinal axis of the filter, and the second curved portion is adapted to extend radially toward the longitudinal axis of the filter. Item 4. The recoverable filter according to item 3.   The recoverable filter of claim 3, wherein the first and second curved portions are adapted to have a non-parallel relationship with the longitudinal axis of the filter.   The recovery according to any of claims 1 to 5, wherein each of the primary struts is formed from a superelastic material, stainless steel wire, nitinol, a cobalt-chromium-nickel-molybdenum-iron alloy, or a cobalt-chromium alloy. Possible filter.   The recovery according to any of claims 1 to 6, wherein each secondary strut is formed from a superelastic material, stainless steel wire, nitinol, a cobalt-chromium-nickel-molybdenum-iron alloy, or a cobalt-chromium alloy. Possible filter.   Multiple pairs of secondary struts are positioned between the pairs of primary struts, and each pair of secondary struts is twisted around each other near their connecting ends to form a twisted portion. The recoverable filter according to any one of claims 1 to 7.   9. The filter of claim 8, wherein each of the twisted portions has approximately 1 to 10 twists. 10. A recoverable filter according to any preceding claim, wherein the primary and secondary struts are formed from a shape memory alloy having a transition temperature. 11. The recoverable filter of claim 10, wherein the primary and secondary struts are folded into the folded state when their temperature is approximately equal to or higher than the transition temperature. 11. The recoverable filter of claim 10, wherein the primary and secondary struts expand to the expanded state when their temperature is approximately equal to or higher than the transition temperature.   13. The anchor hook of claim 1 to 12, wherein the anchor hook in the expanded state defines a first shaft portion and the free end of the secondary strut in the expanded state defines a second shaft portion. The filter which can be collect | recovered in any one.

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